Impact of Iron Deficiency Anemia on Neurobehavioral and Cognitive Development in Children Aged 6 to 24 Months

October 25, 2024 updated by: Pingshan District Maternal & Child Healthcare Hospital of Shenzhen

Study on the Association Between Iron Deficiency Anemia and Neurobehavioral Development and Cognitive Function in Children Aged 6 to 24 Months

The goal of this observational study is to explore the relationship between iron-deficiency anemia and neurobehavioral development in children aged 6-24 months. This study focuses on children who undergo health check-ups and blood tests at pediatric health clinics in Pingshan District, Shenzhen, China.

The main questions it aims to answer are:

How does iron-deficiency anemia affect children's neurobehavioral development, including motor skills, language ability, and social behavior? How does anemia influence growth and nutrition, such as weight, height, and body mass index (BMI) in children?

Participants will:

Undergo blood tests (including hemoglobin levels, serum ferritin, and serum iron) to assess anemia status.

Be assessed using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6" to measure motor, cognitive, language, and social development.

Provide general health information, such as birth history, feeding methods, and parental details, through interviews with trained surveyors.

Researchers will compare children with and without iron-deficiency anemia to determine differences in neurobehavioral outcomes and development levels. The findings aim to provide evidence for early interventions to prevent the negative impacts of anemia and support children's healthy development.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Moujinsong Project Manager, M.Sc
  • Phone Number: +86 075528799171
  • Email: 582260375@qq.com

Study Locations

  • China
    • China/Guangdong
      • Shenzhen, China/Guangdong, China, 518118
        • Recruiting
        • Shenzhen Pingshan District Maternity & Child Healthcare Hospital, Department of Child Healthcare
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of children aged 6 to 24 months who attend children health care clinics for routine health check-ups and vaccinations. Participants will be recruited from both hospitals and community health centers within the designated region. The population will include children diagnosed with iron-deficiency anemia and non-anemic controls, providing a comparative sample. The study will aim to capture a diverse range of children from various socioeconomic backgrounds. Informed consent will be obtained from the parents or guardians before participation, and all children will meet the specified inclusion criteria for neurodevelopmental and physical growth evaluations.

Description

Inclusion Criteria:

  • Children aged 6 to 24 months at the time of enrollment
  • Diagnosed with iron-deficiency anemia (for the exposure group) or confirmed
  • non-anemic status (for the control group) based on blood test results
  • Resident in the study area for at least 6 months prior to enrollment
  • Availability of parental or guardian consent to participate in the study and willingness to follow study protocols
  • Completion of all baseline assessments, including neurodevelopmental and physical growth evaluations

Exclusion Criteria:

  • Presence of congenital or chronic illnesses that could affect
  • neurodevelopment, such as Down syndrome or cerebral palsy.
  • History of severe infections or trauma within 3 months prior to enrollment that
  • could influence neurodevelopmental outcomes
  • Current use of medications or treatments that may interfere with iron metabolism (e.g., iron supplementation or blood transfusions in the last 6 months)
  • Premature birth (before 37 weeks of gestation) or low birth weight (< 2,500 grams)
  • Parental refusal to provide consent or non-compliance with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Iron-Deficient Group
This group consists of children diagnosed with iron-deficiency anemia.
Control Group (Non-Anemic)
This group consists of children without iron-deficiency anemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurobehavioral Development Score
Time Frame: Baseline assessment and follow-up at 6 months.
This measure assesses neurobehavioral development, including motor skills, language, social behavior, and adaptability, using the "Neuropsychological Behavioral Development Scale for Children Aged 0-6." The score is used to determine the developmental status of children in both the iron-deficiency and non-anemic groups.
Baseline assessment and follow-up at 6 months.
Hemoglobin (Hb)
Time Frame: Blood samples will be taken at baseline and follow-up at 3 months.
To assess the severity of anemia.
Blood samples will be taken at baseline and follow-up at 3 months.
Serum Ferritin
Time Frame: Blood samples will be taken at baseline and follow-up at 3 months
To evaluate the iron stores in the body
Blood samples will be taken at baseline and follow-up at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Growth (Height)
Time Frame: Baseline assessment and follow-up at 6 months.
This measure evaluates the physical growth of children, specifically tracking changes in height. Growth data will be compared between children with iron-deficiency anemia and those without to assess the impact of anemia on physical development.
Baseline assessment and follow-up at 6 months.
Physical Growth ( Weight)
Time Frame: Baseline assessment and follow-up at 6 months.
This measure evaluates children's changes in weight. Weight data will be compared between children with and without iron-deficiency anemia to assess anemia's impact on their physical development.
Baseline assessment and follow-up at 6 months.
Physical Growth (BMI)
Time Frame: Baseline assessment and follow-up at 6 months.
This measure assesses children's physical growth by tracking changes in BMI. BMI (Body Mass Index) is calculated by dividing a child's weight (kg) by the square of their height (m²). BMI values will be compared between children with and without iron-deficiency anemia to evaluate anemia's impact on physical development.
Baseline assessment and follow-up at 6 months.
Eating behavior
Time Frame: Collected at baseline.
Eating behavior was assessed using the Children's Eating Behaviour Questionnaire (CEBQ), which evaluates various aspects of children's eating habits, such as food responsiveness, enjoyment of food, and satiety responsiveness. The CEBQ scores will be compared between children with and without iron-deficiency anemia to evaluate how anemia might impact their eating behavior and, in turn, their physical development.
Collected at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pingshan District Maternal & Child Healthcare Hospital of Shenzhen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Access Criteria

Researchers interested in accessing the individual participant data (IPD) and supporting information can submit a formal request via email to moujs@foxmail.com. Access will be granted to qualified researchers from academic or research institutions, and they will receive de-identified IPD along with supporting documents like the study protocol and statistical analysis plan. Requests must include a research proposal and will be reviewed for compliance with ethical and privacy standards.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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